Mindfulness-Based VR for Family Caregivers of People With Dementia

NCT06034249 | Completed DMC

• 1 other identifier: 20230816
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore the effectiveness of mindfulness-based VR could enhance depression, sleep quality, and overall quality of life for family caregivers providing care for people with dementia. Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices. The control group will only be given the mindfulness-based audio files for six weeks.

Conditions

Caregivers of People With Dementia; Quality of Life

Keywords

Virtual Reality; Depression; Sleep Quality

Outcome Measures

Primary Outcomes (1)

• Depression

  The Center for Epidemiologic Studies Depression Scale (CES-D) The minimum value= 0, maximum value= 60, higher score mean higher frequency of depressive symptoms.

  Baseline and six-week

Secondary Outcomes (2)

• Sleep

  Baseline and six-week

• QoL

  Baseline and six-week

Study Arms (2)

Experimental Group: Mindfulness-Based VR group

EXPERIMENTAL

Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices.

Behavioral: Mindfulness-Based VR

Control Group: Mindfulness-based Audio Files

PLACEBO COMPARATOR

The control group will only be given the mindfulness-based audio files for six weeks.

Behavioral: Audio

Interventions

Mindfulness-Based VR BEHAVIORAL

Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices.

Experimental Group: Mindfulness-Based VR group

Audio BEHAVIORAL

The mindfulness-based audio files for six weeks.

Control Group: Mindfulness-based Audio Files

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being a family caregiver responsible for caring for a family member diagnosed with dementia by a medical institution,
• having the ability to communicate in Mandarin or Taiwanese, and
• providing informed consent to participate in the study by signing the consent form.

You may not qualify if:

• Visual and auditory impairments were excluded from the study.

Sponsors & Collaborators

• Taipei Medical University: lead
• National Science and Technology Council: collaborator

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Megan F Liu, PhD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomized controlled trial (RCT) design was used. Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices. The control group will only be given the mindfulness-based audio files for six weeks.

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: August 23, 2022
• Primary Completion: November 21, 2022
• Study Completion: June 6, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)